Enshuangping Metformin Hydrochloride and Empagliflozin Tablets (I)

1. Indications and Usage
Indicated as an adjunct to diet and exercise to improve glycemic control in adult patients who are suitable for treatment with empagliflozin and metformin.
2. Dosage and Administration
Recommended Dosage: The recommended starting dosage is one tablet (500 mg metformin/5 mg empagliflozin) twice daily with meals.
Titration: The dosage should be individualized based on glycemic response and tolerability. The maximum recommended daily dosage is 1000 mg metformin and 25 mg empagliflozin.
Renal Function: Do not initiate treatment if eGFR is below 45 mL/min/1.73 m². Evaluate renal function before starting and periodically thereafter.
3. Mechanism of Action
Metformin: A biguanide that decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Empagliflozin: An inhibitor of the sodium-glucose cotransporter 2 (SGLT2) in the kidney. It increases urinary glucose excretion, lowering blood glucose levels independently of insulin.
4. Safety and Warnings
Lactic Acidosis: A rare but serious complication; discontinue if clinical or laboratory findings suggest lactic acidosis. Risk is increased in renal impairment and hypoxic states.
SGLT2 Inhibitor Class Warnings: Includes risk of diabetic ketoacidosis (DKA), serious urinary tract and genital mycotic infections, acute kidney injury, and volume depletion.
Hypersensitivity: Serious hypersensitivity reactions (e.g., angioedema, Stevens-Johnson syndrome) have been reported with empagliflozin.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Nasopharyngitis, upper respiratory tract infection, urinary tract infection, genital mycotic infections, diarrhea, and nausea.
Clinical Research: Clinical trials have demonstrated that this combination significantly reduces HbA1c and fasting plasma glucose compared to monotherapy components.
6. Drug Interactions
Alcohol: Chronic alcohol intake increases risk of metformin-associated lactic acidosis.
Cationic Drugs: Drugs such as cimetidine may affect metformin renal clearance; dose adjustment may be necessary.
Insulin and Sulfonylureas: May increase the risk of hypoglycemia when used concomitantly.
7. Pharmaceutical Information
Composition: Active ingredients are metformin hydrochloride and empagliflozin.
Appearance: Film-coated tablets; white to off-white.
Storage: Store at controlled room temperature in a tight, light-resistant container.